UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016612 |
|---|---|
| Receipt number | R000019280 |
| Scientific Title | AFIRE Study: Atrial Fibrillation and Ischemic events with Rivaroxaban in patiEnts with stable coronary artery disease Study |
| Date of disclosure of the study information | 2015/02/23 |
| Last modified on | 2019/03/27 09:00:32 |
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Basic information
Public title
AFIRE Study: Atrial Fibrillation and Ischemic events with Rivaroxaban in patiEnts with stable coronary artery disease Study
Acronym
AFIRE Study
Scientific Title
AFIRE Study: Atrial Fibrillation and Ischemic events with Rivaroxaban in patiEnts with stable coronary artery disease Study
Scientific Title:Acronym
AFIRE Study
Region
| Japan |
Condition
Condition
Non-valvular atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of rivaroxaban monotherapy compared to rivaroxaban in co-administration with a single anti-platelet therapy in non-valvular atrial fibrillation patients with stable coronary artery diseases.
For the efficasy of rivaroxaban monotherapy, for the composite endpoint incidence of cardiovascular events or all-cause mortality for the rivaroxaban and anti-platelet drugs single agent combination therapy to verify the non-inferiority. for safety, to verify the superiority for serious bleeding complications incidence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Primary efficacy endpoints
Composite endpoint of cardiovascular events (stroke, non-CNS embolism, myocardial infarction, unstable angina pectoris requiring revascularizations or all-cause mortality)
(2)Safety primary endpoints
Major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH)
Key secondary outcomes
1)Net adverse clinical and cerebral events (NACCE) (net clinical benefit)
All-cause death, myocardial infarction, stroke and major bleeding
2)Ischemic cardiovascular events and death
(1)All-cause mortality
(2)Cardiovascular death
(3)Non-cardiovascular death
(4)Myocardial infarction
(5)Unstable angina pectoris requiring revascularization
(6)Ischemic stroke
(7)Transient ischemic attack
(8)Systemic embolism
(9)PCI/CABG
(10)Stent thrombosis
(11)Ischemic stroke and systemic embolism
3)Any bleeding
4)Adverse events excluding hemorrhagic events
5)Comparison of the primary endpoints between patients treated with aspirin and treated with thienopyridine derivatives
6)Stratified analysis of the primary endpoints, ischemic cardiovascular events and mortality according to the CHADS2 score and CHA2DS2-VASc score
7)Stratified analysis of the incidences of the primary endpoints, ischemic cardiovascular events and mortality according to subject characteristics
8)Stratified analysis of major bleeding and all bleeding events in patients treated concomitantly with any antiplatelet and patients not treated with any antiplatelet according to the HAS-BLED score and analysis of specificity and sensitivity
9)Comparison of the incidence of bleeding events according to whether or not proton pump inhibitors (PPIs) are used
10)Comparison of the incidences of the primary endpoints according to whether rivaroxaban is administered in the morning or evening
11)Investigation of relationships between ischemic cardiovascular events, bleeding events/adverse events and discontinuation of treatment with antithrombotic agents
12)Investigation of relationships between prothrombin time at trough and bleeding events and the cutoff values according to whether or not antiplatelet drugs are concomitantly used
13)The incidence of the primary endpoints according to adherence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rivaroxaban monotherapy
Rivaroxaban will be orally administered at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min until end of study.
Interventions/Control_2
Rivaroxaban co-administered with single anti-platelet therapy
Rivaroxaban and a single antiplatelet will be orally administered until end of study. Antiplatelet will be selected from aspirin or thienopyridine derivatives (clopidogrel or prasugrel).
Rivaroxaban administration: Rivaroxaban will be orally administered after a meal at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min (regardless of time).
Aspirin administration: Aspirin will be orally administered once a day at a dose of 81 mg or 100 mg.
Clopidogrel administration: Clopidogrel will be orally administered once a day after a meal at a dose of 75 mg. The dose will be reduced to 50mg once a day by consideration for aging, body weight or clinical findings.
Prasugrel administration: Prasugrel will be orally administered once a day at a dose of 3.75 mg. If the body weight is 50kg or less than 50kg, the dose will be considered to reduce to 2.5 mg once a daily by evaluation for aging, renal function or other bleeding risk and thrombotic risk.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with non-valvular atrial fibrillation complicated with stable coronary artery disease who are 20 years or more at the obtaining of informed consent, CHADS2 score are 1 or more, and fulfil the criteria below and can provide written consent for participation in the present study will be eligible.
1) Patients who underwent percutaneous coronary intervention, including plain old balloon angioplasty, at least one year ago
2) Patients who have coronary stenosis requiring no percutaneous coronary intervention (50% or more stenosis) as indicated by coronary CT or coronary angiography
3) Patients who underwent coronary artery bypass graft CABG at least one year ago
Key exclusion criteria
1)Patients who are contraindicated for rivaroxaban
2)Patients who are contraindicated for aspirin, thienopyridine derivatives (clopidogrel or prasugrel)
3)Patients who underwent PCI, including POBA, in the past one year
4)Patients who are going to undergo revascularization
5)Patients who have a past history of stent thrombosis
6)Those who are going to undergo invasive surgery (excluding digestive endoscopy and biopsy)
7)Patients who have active tumors
8)Patients who have poorly-controlled hypertension (systolic blood pressure at hospital admission based on two or more measurements: 160 mmHg or more)
9)Patients who cannot discontinue treatment with antiplatelet drugs (the physician in charge will make a decision on the basis of the lesion shape, lesion site and type of stents.)
(10)Patients judged as inappropriate for this study by investigators
Contraindicated for rivaroxaban
(1)Unstable CAD
(2)Patients with a past history of stent thrombosis
(3)Patients judged as inappropriate for this study by investigators
Target sample size
2200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi yasuda |
Organization
Japan Cardiovascular Research Foundaition
Division name
National Cerebral and Cardiovascular Center
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka 565-8565, Japan
TEL
+81-6-6872-0010
afire@jcvrf.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saburo Saito |
Organization
Japan Cardiovascular Research Foundation
Division name
Administration Office
Zip code
Address
5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL
06-6872-0010
Homepage URL
afire@jcvrf.jp
Sponsor or person
Institute
Japan Cardiovascular Research Foundation
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin , Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
独立行政法人 国立循環器病研究センター（大阪府）
熊本大学医学部附属病院（熊本県）
大阪医科大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019280
